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临床试验/ACTRN12623000953639
ACTRN12623000953639招募中Unknown

The efficacy of foot orthoses for midfoot osteoarthritis: a randomised controlled trial

a Trobe University0 个研究点目标入组 140 人开始时间: 2023年9月4日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
140

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • (i) Aged 18 years and over
  • (ii) Pain in the midfoot joints that has been present for at least 3 months, located in at least one area in a predetermined dorsal midfoot region, that is aggravated by weightbearing activities
  • (iii) Average pain in the midfoot when walking during the last 7 days is rated at least 3 out of 10 in severity on an 11-point numerical rating scale (NRS) (where 0 represents no pain and 10 represents the worst pain imaginable)
  • (iv) Have radiographic evidence of midfoot osteoarthritis confirmed using the La Trobe University Atlas of foot osteoarthritis – a minimum score of 1 for either observations of joint space narrowing or osteophytes in at least one of the midfoot joints in either radiographic view
  • (v) Able to walk household distances (>50 metres) without walking aids
  • (vi) Willing to regularly wear shoes that will accommodate shoe inserts
  • (vii) Willing to attempt to not receive additional interventions during the study period

排除标准

  • (i) Previous ipsilateral foot surgery or planning surgery in the next 12 weeks
  • (ii) Osteoarthritis secondary to other issues such as major trauma
  • (iii) Presence of other foot or ankle condition(s) or have pain in another location that is greater than the pain in the midfoot
  • (iv) Any musculoskeletal or systemic medical conditions (e.g., suspected inflammatory joint disease, neurological) that could make the participant unsuitable for inclusion or confound pain and functional assessments of the midfoot
  • (v) Any inability to speak and read English
  • (vi) Any treatment that includes the use of any foot orthoses (including shock absorption shoe inserts), ankle braces and/ or, received intra-articular injections at the midfoot in the previous 12 weeks
  • (vii) Dementia or any cognitive impairment

研究者

发起方
a Trobe University

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